AstraZeneca announces renewed recommendation and availability of FLUMIST QUADRIVALENT vaccine in the US

Positive study results presented at the February 2018 ACIP meeting show that the new H1N1 LAIV strain induces improved antibody responses

AstraZeneca today announced that the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) has voted in favor of a renewed recommendation for the use of FLUMIST® QUADRIVALENT (Influenza Vaccine Live, Intranasal) in the US for the 2018-2019 season. The recommendation follows the presentation of positive results from a US study in children between the ages of 2 to <4 years evaluating the shedding and antibody responses of the H1N1 strain in the live attenuated influenza vaccine (LAIV)/FLUMIST QUADRIVALENT.

Study results demonstrated that the new 2017-2018 H1N1 LAIV post-pandemic strain (A/Slovenia) performed significantly better than the 2015-2016 H1N1 LAIV post-pandemic strain (A/Bolivia), which was previously associated with reduced effectiveness. The antibody response induced with the new H1N1 LAIV strain was comparable to earlier data seen with the highly effective H1N1 LAIV strain included in the vaccine before the 2009 influenza pandemic.

Gregory Keenan, Vice President, US Medical Affairs, AstraZeneca, said: “This study validates the improvements we’ve made to our strain selection process and confirms an improved H1N1 LAIV strain was included in the 2017-2018 formulation. We are pleased that the ACIP has voted in support of a renewed recommendation for FLUMIST QUADRIVALENT in the US and look forward to continuing to work with public health authorities to optimize protection against influenza.”

FLUMIST QUADRIVALENT is approved for use in the US, Canada and the European Union. Limited quantities of FLUMIST QUADRIVALENT continue to be available in the US for the current 2017-2018 season. FLUMIST QUADRIVALENT will be available in the US for the 2018-2019 influenza season, pending annual strain approval from the US Food and Drug Administration (FDA). The vaccine has remained recommended for use and available in Canada and EU.

The full results of AstraZeneca’s US pediatric clinical study evaluating the shedding and antibody responses of the H1N1 strain in the LAIV/FLUMIST QUADRIVALENT will be presented at a forthcoming medical meeting.

IMPORTANT SAFETY AND ELIGIBILITY INFORMATION

Who should not get FLUMIST QUADRIVALENT?
You should not get FLUMIST QUADRIVALENT if you have a severe allergy to eggs or to any inactive ingredient in the vaccine; have ever had a life-threatening reaction to influenza vaccinations; or are 2 through 17 years old and take aspirin or medicines containing aspirin – children or adolescents should not be given aspirin for 4 weeks after getting FLUMIST QUADRIVALENT unless your healthcare provider tells you otherwise.

Children under 2 years old have an increased risk of wheezing (difficulty with breathing) after getting FLUMIST QUADRIVALENT.

Who may not be able to get FLUMIST QUADRIVALENT?
Tell your healthcare provider if you or your child are currently wheezing; have a history of wheezing if under 5 years old; have had Guillain-Barré syndrome; have a weakened immune system or live with someone who has a severely weakened immune system; have problems with your heart, kidneys, or lungs; have diabetes; are pregnant or nursing; or are taking Tamiflu®, Relenza®, amantadine, or rimantadine.

Your healthcare provider will decide if FLUMIST QUADRIVALENT is right for you or your child.

What are the most common side effects of FLUMIST QUADRIVALENT?
The most common side effects are runny or stuffy nose, sore throat, and fever over 100°F.

What is FLUMIST QUADRIVALENT?
FLUMIST QUADRIVALENT is a vaccine that is sprayed into the nose to help protect against influenza. It can be used in children, adolescents, and adults ages 2 through 49. FLUMIST QUADRIVALENT is similar to MedImmune’s trivalent influenza vaccine, except FLUMIST QUADRIVALENT provides protection against an additional influenza strain. FLUMIST QUADRIVALENT may not prevent influenza in everyone who gets vaccinated.

Please see complete Product Information, including Prescribing Information.

Tamiflu® and Relenza® are registered trademarks of their respective owners and are not trademarks of MedImmune, LLC.

NOTES TO EDITORS

About the Study
AstraZeneca initiated a clinical study in 200 US children between the ages of 2 to <4 years evaluating the shedding and antibody responses of the new 2017-2018 H1N1 LAIV vaccine (containing the A/Slovenia strain) and the 2015-2016 H1N1 LAIV vaccine (containing the A/Bolivia strain). After the first dose of FLUMIST QUADRIVALENT, 23% of children vaccinated with the 2017-2018 H1N1 LAIV strain developed a 4-fold antibody rise, compared to 5% with the 2015-2016 H1N1 LAIV strain. After the second dose, those results increased to 45% and 12% respectively. The data also demonstrate that the new 2017-2018 H1N1 LAIV strain resulted in increased vaccine virus replication in vaccinated children.  

About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca-us.com and follow us on Twitter @AstraZenecaUS.

CONTACTS

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Michele Meixell                        +1 302 885 2677
Abigail Bozarth                        +1 302 885 2677

 

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